Urinary IncontinencePNS_UDTNCT05128682
Acute Pudendal Nerve Stimulation On Leak Point Pressure In Women Urodynamic Early Feasibility Study
A study testing Urodynamic testing with and without pudendal nerve stimulation in people with Urinary Incontinence, run by Corewell Health East at 2 sites in United States.
Trial summary
The purpose of this study is tp evaluate the changes in stress induced Urethral Leak Point Pressures (LPP) and other urodynamic measurements in response to acute pudendal nerve stimulation (PNS) in patients with a pre-existing implanted urological neurostimulator stimulating the pudendal nerve. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Urodynamic testing with and without pudendal nerve stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 May 2022to 7 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women between the ages of 18 and 85 years old, inclusive.
- Implanted with a neurostimulation device for at least 3 months prior to consent (Medtronic Interstim neurostimulator models 3023, 3058, 97810, or similar).
- Implanted with a tined lead that is placed and functionable at the pudendal nerve (Medtronic model 3889 or similar).
- Is capable of understanding clinical study procedures and giving informed consent.
- Willing and able to visit the clinic for the UDT evaluation (study procedure)
Who cannot join
- Medically unstable at time of study and unsafe to undergo urodynamic testing as determined by the investigator.
- History of bladder cancer.
- History of pelvic radiotherapy.
- Active gross hematuria.
- Active symptomatic urinary tract infection (UTI)
- Active symptomatic uncontrolled bladder instability as determined by the investigator.
Show all 11Show fewer
- History or symptoms of cystocele, enterocele, or rectocele of grade 3 or 4. Per the medical record or as determined by the investigator.
- Presence of an artificial urinary sphincter.
- Women who are pregnant and/or have given birth in the previous 12 months
- Any medical condition that would interfere with the patient's ability to comply with the protocol and/or may affect the outcome of this study or safety of the subject as determined by the investigator
- BMI greater than 39.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Beaumont Hospital - Royal Oak
Royal Oak, Michigan, 48073
Beaumont Hospital Royal Oak
Royal Oak, Michigan, 48073
About this study
Official title: The Effect Of Acute Pudendal Nerve Stimulation On Leak Point Pressure In Women Urodynamic: Early Feasibility Study
The purpose of this study is tp evaluate the changes in stress induced Urethral Leak Point Pressures (LPP) and other urodynamic measurements in response to acute pudendal nerve stimulation (PNS) in patients with a pre-existing implanted urological neurostimulator stimulating the pudendal nerve.
Read the detailed description
Patients with a neurostimulator implanted at the pudendal nerve will be enrolled and undergo urodynamic testing. Before testing, study staff will provide an oral antibiotic (to reduce the risk of infection) and adjust the stimulation settings with a goal to increase urethral pressure from baseline by at lest 20cm H2O, without causing the patient discomfort/distress. These settings will be used throughout urodynamics. Before filling the bladder, a urethral pressure profile study will be completed 3 times with stimulation off, then 3 times with stimulation on. Leak point pressure (LPP) testing will then be completed. The patient's bladder will be filled following standard urodynamic testing protocol. Filling will be paused every 50-100mL to complete LPP assessment. Subjects will be asked to complete a light cough, medium cough, forceful cough, and Valsalva maneuver (in that order). Detrusor pressure will be measured at each event, and staff will document whether or not a leak was elicited. This will be completed with stimulation off, then with stimulation on, as the bladder is filled. Once the subject reports a strong urge to void, urethral pressure profile assessment will be completed again: 3 times with stimulation off, then 3 times with stimulation on. Once urodynamic testing is complete and the patient's bladder is emptied, a measurement of urethral pressure will be completed with stimulation off, then during 5 seconds of stimulation, then again with stimulation off.
- Conditions
- Urinary Incontinence
- Being tested
- Urodynamic testing with and without pudendal nerve stimulation
- Keywords
- pudendal nerve, urinary incontinence
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urodynamic testing with and without pudendal nerve stimulationDiagnostic test
A urodynamic test (UDT) for eligible subjects with and without acute PNS will be conducted. Prior to introducing the acute PNS, the subject's original stimulation properties will be turned off. The implanted neurostimulator device will be programmed to deliver acute PNS per individual tolerance level with the objective of increasing external urethral sphincter pressure. The LPP during Valsalva maneuver or forceful coughing will be assessed with and without acute PNS. The LPP will be assessed at increasing bladder volumes until major detrusor instability, significant leakage (more than drops, stream) or subject discomfort (strong desire to void) is observed. Finally, a UPP with PNS set in an on/off cycling regimen will be conducted to observe the effect on pressures along the length of the urethra.
| Study group | Role | What they receive |
|---|---|---|
| Urodynamic testing with and without pudendal nerve stimulation | Other | The neuromodulation settings of the implanted device will be adjusted to deliver acute simulation. Urodynamic testing (UDT) will be completed by filling the bladder and observing for urinary leakage. The assessment will be completed with the stimulation sets turned off and then turned on. At the end of the UDT the settings will be returned to the previously set therapeutic values. The neuromodulation settings constitute the "dose" and can include the voltage/current amplitude, frequency, pulse width, on time/off time duration and electrode polarity assignments. These parameters are limited by the available ranges of the approved neurostimulation device and will be adjusted during the study by the principal investigator to stay within the safe and comfortable levels for each individual study subject. Receives: Diagnostic Test: Urodynamic testing with and without pudendal nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse Amplitude Triggering Patient Sensation at First Verbally Reported Sensation.
PNS final settings including: pulse amplitude, measured in mA, when subject first verbalizes sensation. Pulse amplitude is the amplitude of the electric pulses; measured in Milliamps (mA). This is a setting present on the neuromodulation device, it is not calculated.
Measured: After Visit 2 activities are complete. An average of 30 days after enrollment.
Pulse Frequency Triggering Patient Sensation at First Verbally Reported Sensation.
PNS final settings including: pulse frequencies, measured in Hz, when subject first verbalizes sensation.
Measured: After Visit 2 activities are complete. An average of 30 days after enrollment.
Pulse Width Triggering Patient Sensation at First Verbally Reported Sensation.
PNS final settings including: pulse widths, measured in µs, when the subject first verbalizes sensation.
Measured: After Visit 2 activities are complete. An average of 30 days after enrollment.
Identification of All Study-related Adverse Events
Safety and tolerability will be assessed in relation to the incidence of study related adverse events reported.
Measured: After Visit 2 activities are complete. An average of 30 days after enrollment.
Changes in Leak Point Pressure (LPP) Upon Acute PNS
Measurement of the change in LPP with acute PNS compared to without stimulation. To assess LPP, the urethral pressure increase will be calculated by subtracted pressure with and without stimulation at the "final setting". In cm water.
Measured: After Visit 2 activities are complete. An average of 30 days after enrollment.
Secondary outcomes (3)
Effect of Acute PNS on the Urethral Pressure Profile (UPP).
Measure the maximum urethral closure pressure with and without programmed pudendal nerve stimulation. In cm water.
Urethral pressure profile is a test of the bladder neck, urethra, and urethral sphincters that is completed with urodynamic equipment. A small catheter is pulled at a constant rate from the bladder neck down the urethra to provide the functional length of the urethra and points of maximal urethral resistance at the urethral sphincter. It is a procedure used to measure the competency of the urethral sphincter (outflow resistance).
Measured: After Visit 2 activities are complete. An average of 30 days after enrollment.
Effect of Acute PNS on Max Cystometic Capacity.
Max cystometic capacity will be collected, with and without programmed PNS, the difference will be reported. In mL.
Measured: After Visit 2 activities are complete. An average of 30 days after enrollment.
Effect of Acute PNS on Post Void Residual.
Post void residual collected at end of UDT testing. Measured in mL.
Measured: After Visit 2 activities are complete. An average of 30 days after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start24 May 2022
- Primary completion27 Jul 2022
- Study completion7 Sep 2022
Why it stopped: This is an early feasibility study. After the first 4 patients completed study activities, the investigator determined that this protocol is not the best way to test the study hypothesis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects who meet all eligibility criteria will be enrolled in the study and will undergo urodynamic testing with UPP.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth M Peters, MD, Corewell Health East
- Investigators
- Kenneth Peters, MD, Principal investigator, Beaumont Hospital - Royal Oak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128682
- Sponsor's protocol ID
- 2021-286
- Acronym
- PNS_UDT
- Status last verified
- May 2023
- First submitted
- 22 Sep 2021
- Last updated
- 16 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Acute Pudendal Nerve Stimulation On Leak Point Pressure In Women Urodynamic: Early Feasibility Study
- ClinicalTrials.gov ID
- NCT05128682
- Acronym / sponsor ID
- PNS_UDT / 2021-286
- Conditions
- Urinary Incontinence
- Keywords
- pudendal nerve, urinary incontinence
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This is an early feasibility study. After the first 4 patients completed study activities, the investigator determined that this protocol is not the best way to test the study hypothesis.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- 24 May 2022 (actual)
- Primary completion
- 27 Jul 2022 (actual)
- Study completion
- 7 Sep 2022 (actual)
- First posted
- 22 Nov 2021 (actual)
- Results
- Posted 16 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is tp evaluate the changes in stress induced Urethral Leak Point Pressures (LPP) and other urodynamic measurements in response to acute pudendal nerve stimulation (PNS) in patients with a pre-existing implanted urological neurostimulator stimulating the pudendal nerve.
Detailed description
Patients with a neurostimulator implanted at the pudendal nerve will be enrolled and undergo urodynamic testing. Before testing, study staff will provide an oral antibiotic (to reduce the risk of infection) and adjust the stimulation settings with a goal to increase urethral pressure from baseline by at lest 20cm H2O, without causing the patient discomfort/distress. These settings will be used throughout urodynamics. Before filling the bladder, a urethral pressure profile study will be completed 3 times with stimulation off, then 3 times with stimulation on. Leak point pressure (LPP) testing will then be completed. The patient's bladder will be filled following standard urodynamic testing protocol. Filling will be paused every 50-100mL to complete LPP assessment. Subjects will be asked to complete a light cough, medium cough, forceful cough, and Valsalva maneuver (in that order). Detrusor pressure will be measured at each event, and staff will document whether or not a leak was elicited. This will be completed with stimulation off, then with stimulation on, as the bladder is filled. Once the subject reports a strong urge to void, urethral pressure profile assessment will be completed again: 3 times with stimulation off, then 3 times with stimulation on. Once urodynamic testing is complete and the patient's bladder is emptied, a measurement of urethral pressure will be completed with stimulation off, then during 5 seconds of stimulation, then again with stimulation off.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects who meet all eligibility criteria will be enrolled in the study and will undergo urodynamic testing with UPP.
| Arm | Type | Receives |
|---|---|---|
| Urodynamic testing with and without pudendal nerve stimulation | Other | Diagnostic Test: Urodynamic testing with and without pudendal nerve stimulationThe neuromodulation settings of the implanted device will be adjusted to deliver acute simulation. Urodynamic testing (UDT) will be completed by filling the bladder and observing for urinary leakage. The assessment will be completed with the stimulation sets turned off and then turned on. At the end of the UDT the settings will be returned to the previously set therapeutic values. The neuromodulation settings constitute the "dose" and can include the voltage/current amplitude, frequency, pulse width, on time/off time duration and electrode polarity assignments. These parameters are limited by the available ranges of the approved neurostimulation device and will be adjusted during the study by the principal investigator to stay within the safe and comfortable levels for each individual study subject. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women between the ages of 18 and 85 years old, inclusive.
- Implanted with a neurostimulation device for at least 3 months prior to consent (Medtronic Interstim neurostimulator models 3023, 3058, 97810, or similar).
- Implanted with a tined lead that is placed and functionable at the pudendal nerve (Medtronic model 3889 or similar).
- Is capable of understanding clinical study procedures and giving informed consent.
- Willing and able to visit the clinic for the UDT evaluation (study procedure)
Key exclusion criteria (11 listed)
- Medically unstable at time of study and unsafe to undergo urodynamic testing as determined by the investigator.
- History of bladder cancer.
- History of pelvic radiotherapy.
- Active gross hematuria.
- Active symptomatic urinary tract infection (UTI)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urodynamic testing with and without pudendal nerve stimulationA urodynamic test (UDT) for eligible subjects with and without acute PNS will be conducted. Prior to introducing the acute PNS, the subject's original stimulation properties will be turned off. The implanted neurostimulator device will be programmed to deliver acute PNS per individual tolerance level with the objective of increasing external urethral sphincter pressure. The LPP during Valsalva maneuver or forceful coughing will be assessed with and without acute PNS. The LPP will be assessed at increasing bladder volumes until major detrusor instability, significant leakage (more than drops, stream) or subject discomfort (strong desire to void) is observed. Finally, a UPP with PNS set in an on/off cycling regimen will be conducted to observe the effect on pressures along the length of the urethra. | Diagnostic test | Urodynamic testing with and without pudendal nerve stimulation |
Primary outcome
Pulse Amplitude Triggering Patient Sensation at First Verbally Reported Sensation.
Time frame: After Visit 2 activities are complete. An average of 30 days after enrollment.
PNS final settings including: pulse amplitude, measured in mA, when subject first verbalizes sensation. Pulse amplitude is the amplitude of the electric pulses; measured in Milliamps (mA). This is a setting present on the neuromodulation device, it is not calculated.
Pulse Frequency Triggering Patient Sensation at First Verbally Reported Sensation.
Time frame: After Visit 2 activities are complete. An average of 30 days after enrollment.
PNS final settings including: pulse frequencies, measured in Hz, when subject first verbalizes sensation.
Pulse Width Triggering Patient Sensation at First Verbally Reported Sensation.
Time frame: After Visit 2 activities are complete. An average of 30 days after enrollment.
PNS final settings including: pulse widths, measured in µs, when the subject first verbalizes sensation.
Identification of All Study-related Adverse Events
Time frame: After Visit 2 activities are complete. An average of 30 days after enrollment.
Safety and tolerability will be assessed in relation to the incidence of study related adverse events reported.
Changes in Leak Point Pressure (LPP) Upon Acute PNS
Time frame: After Visit 2 activities are complete. An average of 30 days after enrollment.
Measurement of the change in LPP with acute PNS compared to without stimulation. To assess LPP, the urethral pressure increase will be calculated by subtracted pressure with and without stimulation at the "final setting". In cm water.
3 secondary outcomes
Effect of Acute PNS on the Urethral Pressure Profile (UPP).
Time frame: After Visit 2 activities are complete. An average of 30 days after enrollment.
Effect of Acute PNS on Max Cystometic Capacity.
Time frame: After Visit 2 activities are complete. An average of 30 days after enrollment.
Effect of Acute PNS on Post Void Residual.
Time frame: After Visit 2 activities are complete. An average of 30 days after enrollment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Peters, MD principal investigator
Beaumont Hospital - Royal Oak
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urodynamic testing with and without pudendal nerve stimulation in people with Urinary Incontinence, run by Corewell Health East at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse Amplitude Triggering Patient Sensation at First Verbally Reported Sensation. (time frame: After Visit 2 activities are complete. An average of 30 days after enrollment.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.